CEFTAZIDIME 1G POWDER FOR SOLUTION FOR INJECTION/INFUSION

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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Ceftazidime 250 mg Powder for Solution for Injection
Ceftazidime 500 mg Powder for Solution for Injection
Ceftazidime 1 g Powder for Solution for Injection/Infusion
Ceftazidime 2 g Powder for Solution for Injection/Infusion
Ceftazidime
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Ceftazidime is and what it is
used for
2. What you need to know before you
are given Ceftazidime
3. How Ceftazidime is given
4. Possible side effects
5. How to store Ceftazidime
6. Contents of the pack and other
information

1

What Ceftazidime is and
what it is used for

Ceftazidime is an antibiotic used in
adults and children (including newborn
babies). It works by killing bacteria that
cause infections. It belongs to a group of
medicines called cephalosporins.
Ceftazidime is used to treat severe
bacterial infections of:
• the lungs or chest
• the lungs and bronchi in patients
suffering from cystic fibrosis
• the brain (meningitis)
• the ear
• the urinary tract
• the skin and soft tissues
• the abdomen and abdominal wall
(peritonitis)
• the bones and joints.
Ceftazidime can also be used:
• to prevent infections during prostate
surgery in men
• to treat patients with low white blood
cell counts (neutropenia) who have a
fever due to a bacterial infection.

2

What you need to know
before you are given
Ceftazidime

You must not be given Ceftazidime:
• if you are allergic (hypersensitive) to
ceftazidime or any of the other
ingredients of this medicine (listed in
section 6)
• if you have ever had a severe allergic
reaction to any other antibiotic
(penicillins, monobactams and
carbapenems) as you may also be
allergic to Ceftazidime.
→ Tell your doctor before you start on
Ceftazidime if you think that this applies
to you. You must not be given
Ceftazidime.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Ceftazidime
You must look out for certain symptoms
such as allergic reactions, nervous
system disorders and gastrointestinal
disorders such as diarrhoea while you
are being given Ceftazidime. This will
reduce the risk of possible problems.
See (‘Conditions you need to look out
for’) in Section 4. If you have had an
allergic reaction to other antibiotics you
may also be allergic to Ceftazidime.
If you need a blood or urine test
Ceftazidime can affect the results of
urine tests for sugar and a blood test
known as the Coombs test. If you are
having tests:
→ Tell the person taking the sample
that you have been given Ceftazidime.
Other medicines and Ceftazidime:
Tell your doctor or pharmacist if you are
taking, have recently taken, or might take
any other medicines.
You shouldn’t be given Ceftazidime
without talking to your doctor if you are
also taking:
• an antibiotic called chloramphenicol
• a type of antibiotic called

The following information is intended
for medical or healthcare
professionals only:
Method and route of administration of
Ceftazidime
Method of Administration
- intravenously
- deep intramuscular injection into a
large muscle mass
Incompatibilities
Ceftazidime should not be mixed with
solutions with a pH above 7.5 for
example sodium bicarbonate solution for
injection.
Ceftazidime and aminoglycosides should
not be mixed in the solution for injection
because of the risk for precipitation.
Cannulae and catheters for intravenous
use should be flushed with physiological
salt-solution between administrations of
ceftazidime and vancomycin to avoid
precipitation.
Instructions for use and handling
Intramuscular administration:
Ceftazidime should be reconstituted with
Water for Injections PhEur or 0.5% or 1%
Lidocaine Hydrochloride Injection BP as
indicated in the table below. The Product
Information for Lidocaine should be
consulted before reconstitution of
ceftazidime with lidocaine.
Intravenous administration:
For direct intermittent intravenous
administration, reconstitute ceftazidime
with Water for Injections PhEur (see
table below). Slowly inject the solution
directly into the vein over a period of up
to 5 minutes or give through the tubing of
a giving set.
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aminoglycosides e.g. gentamicin,
tobramycin
• water tablets called furosemide.
→ Tell your doctor if this applies to you.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding,
think you might be pregnant or are
planning to have a baby ask your doctor
or pharmacist for advice before taking
this medicine.
Your doctor will consider the benefit of
treating you with Ceftazidime against the
risk to your baby.
Your doctor will consider the benefit of
treating you with Ceftazidime against the
risk to your baby.
Driving and using machines:
Ceftazidime can cause side effects that
affect your ability to drive, such as
dizziness.
Don’t drive or use machines unless you
are sure you’re not affected.
Ceftazidime contains sodium
You need to take this into account if you
are on a controlled sodium diet.
Ceftazidime contains 13 mg sodium per
250 mg dose, 26 mg sodium per 500 mg
dose, 52 mg sodium per 1 g dose and
104 mg sodium per 2 g dose.

3

How Ceftazidime is given

Always use this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
Ceftazidime is usually given by a
doctor or nurse. It can be given as a
drip (intravenous infusion) or as an
injection directly into a vein or into a
muscle.
Ceftazidime is made up by the doctor,
pharmacist or nurse using water for
injections or a suitable infusion fluid.
The recommended dose
The correct dose of Ceftazidime for you
will be decided by your doctor and
depends on: the severity and type of
infection; whether you are on any other
antibiotics; your weight and age; how
well your kidneys are working.
Newborn babies (0-2 months)
For every 1 kg the baby weighs, they’ll
be given 25 to 60 mg Ceftazidime per
day divided in two doses.
Babies (over 2 months) and children
who weigh less than 40 kg
For every 1 kg the baby or child
weighs, they’ll be given 100 to 150 mg
of Ceftazidime per day divided in three
doses. Maximum 6 g per day.
Adults and adolescents who weigh
40 kg or more
1 to 2 g of Ceftazidime three times daily.
Maximum of 9 g per day.
Patients over 65
The daily dose should not normally
exceed 3 g per day, especially if you are
over 80 years of age.

Continued on the next page >>

For intravenous infusion, reconstitute the
1 g or 2 g infusion vial with 40 ml Water
for Injections PhEur or one of the
compatible intravenous fluids.
Alternatively, reconstitute the 250 mg,
500 mg, 1 g or 2 g vial and add an
appropriate quantity of the resulting
solution to an IV container with one of
the compatible intravenous fluids.
Intermittent intravenous infusion with a
Y-type giving set can be accomplished
with compatible solutions. However,
during infusion of a solution containing
ceftazidime, it is desirable to discontinue
the other solution.
Preparation of Solutions of Ceftazidime
Amount
of
diluent
to be
added
(ml)

Approx
available
volume
(ml)

Approx
ceftazidime
concentration
(mg/ml)

Intramuscular
1.0
250 mg
1.5
500 mg
3.0
1g

1.20
2.10
3.80

208
238
263

Intravenous
250 mg
500 mg
1g
2g

2.5
5
10
10

2.80
5.50
11.00
11.50

89
91
91
174

Infusion
1g
2g

40*
40*

41
42

25
50

*Note: Addition should be in 2 stages (see
‘Instructions for reconstitution’ below)

Continued on the next page >>

Patients with kidney problems
You may be given a different dose to the
usual dose. The doctor or nurse will
decide how much Ceftazidime you will
need, depending on the severity of the
kidney disease. Your doctor will check
you closely and you may have more
regular kidney function tests.
If you take more Ceftazidime than you
should
If you accidentally use more than your
prescribed dose, contact your doctor or
nearest hospital straight away.
If you forget to take Ceftazidime
If you miss an injection, you should have
it as soon as possible. However, if it is
almost time for your next injection, skip
the missed injection. Do not take a
double dose (two injections at the same
time) to make up for a missed dose.
If you stop using Ceftazidime
Don’t stop taking Ceftazidime unless
your doctor tells you to. If you have any
questions ask your doctor,
pharmacist or nurse.

4

Possible side effects

Like all medicines Ceftazidime can
cause side effects, although not
everybody gets them.
Conditions you need to look out for
The following serious side effects have
occurred in a small number of people but
their exact frequency is unknown:
• Severe allergic reaction. Signs
include raised and itchy rash,
swelling, sometimes of the face or
mouth causing difficulty in breathing
• Skin rash, which may blister, and
looks like small targets (central dark
spot surrounded by a paler area, with
a dark ring around the edge)
• A widespread rash with blisters and
peeling skin. (These may be signs of
Stevens-Johnson syndrome or toxic
epidermal necrolysis)
• Nervous system disorders: tremors,
fits and, in some cases coma. These
have occurred in people when the
dose they are given is too high,
particularly in people with kidney
disease.
• There have been rare reports of
severe hypersensitivity reactions with
severe rash, which may be
accompanied by fever, fatigue,
swelling of the face or lymph glands,
increase of eosinophils (type of white
blood cells), effects on liver, kidney or
lung (a reaction called DRESS).
→ Contact a doctor or nurse
immediately if you get any of
these symptoms.
Common side effects
These may affect up to 1 in 10 people:
• diarrhoea
• swelling and redness along a vein
• red raised skin rash which may be
itchy
• pain, burning, swelling or inflammation
at the injection site.
→ Tell your doctor if any of these are
troubling you.
Common side effects that may show up
in blood tests:
• an increase in a type of white blood
cell (eosinophilia)
• an increase in the number of cells that
help the blood to clot
• an increase in liver enzymes.
Uncommon side effects
These may affect up to 1 in 100 people:
• inflammation of the gut which can
cause pain or diarrhoea which may
contain blood
• thrush - fungal infections in the mouth
or vagina
• headache
• dizziness
• stomach ache
• feeling sick or being sick
• fever and chills.
→ Tell your doctor if you get any of
these.
Uncommon side effects that may show
up in blood tests:
• a decrease in the number of white
blood cells
• a decrease in the number of blood
platelets (cells that help the blood to
clot)

• an increase in the level of urea, urea
nitrogen or serum creatinine in the
blood.
Other side effects
Not known: frequency cannot be
estimated from the available data:
• inflammation or failure of the kidneys
• pins and needles
• unpleasant taste in the mouth
• yellowing of the whites of the eyes or
skin.
Other side effects that may show up in
blood tests:
• red blood cells destroyed too quickly
• an increase in a certain type of white
blood cells
• severe decrease in the number of
white blood cells.
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme
(www.mhra.gov.uk/yellowcard). By
reporting side effects you can help
provide more information on the safety of
this medicine.

5

How to store Ceftazidime

Keep this medicine out of the sight and
reach of children.
• The solutions should be used
immediately after their reconstitution
• Only clear solutions should be used
• The contents of the vials, once
opened, should be used immediately
• Any unused injection or infusion
solutions should be disposed of.
Keep the vial in the outer carton to
protect it from light.
Do not use Ceftazidime after the expiry
date, which is stated on the pack. The
expiry date refers to the last day of that
month.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment.

6

Contents of the pack and
other information

What Ceftazidime contains
The active substance is ceftazidime
pentahydrate.
Each 0.3203 g vial contains 0.2912 g
ceftazidime pentahydrate, corresponding
to 250 mg ceftazidime.
Each 0.6406 g vial contains 0.5824 g
ceftazidime pentahydrate, corresponding
to 500 mg ceftazidime.
Each 1.2813 g vial contains 1.1648 g
ceftazidime pentahydrate, corresponding
to 1 g ceftazidime.
Each 2.5625 g vial contains 2.3296 g
ceftazidime pentahydrate, corresponding
to 2 g ceftazidime.
Other ingredients: sodium carbonate
anhydrous
What Ceftazidime looks like and
contents of the pack
Ceftazidime is a white to cream-coloured
powder.
The reconstituted solution is light yellow
to amber.
Do not use Ceftazidime if you notice the
following: The solution is not clear.
Ceftazidime is supplied in individual
packs of 1 vial as well as in hospital
packs for 5/10/25/50.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Sandoz Ltd.,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Sandoz GmbH,
Biochemiestrasse 10, 6250 Kundl,
Austria.
This leaflet was last revised in
04/2015.

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When ceftazidime is dissolved, carbon
dioxide is released and a positive
pressure develops. For ease of use,
follow the recommended techniques of
reconstitution described below.
Instructions for reconstitution:
For 250 mg im/IV, 500 mg im/IV, 1 g
im/IV and 2 g IV vials
1. Inject the diluent and shake well to
dissolve. The vials may contain a
vacuum to assist injection of the
diluent
2. Carbon dioxide is released as the
antibiotic dissolves, generating
pressure within the vial. The solution
will become clear within 1 to 2
minutes
3. Invert the vial and completely depress
the syringe plunger prior to insertion
4. Insert the needle through the vial
stopper. Be sure the needle remains
within the solution and withdraw
contents of the vial in the usual
manner. Pressure in the vial may aid
withdrawal
5. The withdrawn solution may contain
carbon dioxide bubbles, which should
be expelled from the syringe before
injection.

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mat.no.: 00000000

For 1 g and 2 g infusion vials
1. Inject 10 ml of the diluent and shake
to dissolve. The vials may contain a
vacuum to assist injection of the
diluent
2. Carbon dioxide is released as the
antibiotic dissolves, generating
pressure within the vial. The solution
will become clear within 1 to 2
minutes
3. Insert a vent needle to release
pressure before adding additional
diluent to the vial. Add diluent and
then remove the vent needle

4. Additional pressure that may develop
in the vial, especially after storage,
should be relieved prior to
administration to the patient.
NOTE: To preserve product sterility, it is
important that a gas relief needle is not
inserted through the vial closure before
the product has dissolved.
Single use only.
Unused solution should be discarded.
Only clear solutions practically free from
particles should be used.
Free from bacterial endotoxins.
The colour of the ceftazidime solutions
range from light yellow to amber
depending on concentration, diluent and
storage conditions used. Within the
stated recommendations, the product
potency is not adversely affected by such
colour variations.
At ceftazidime concentrations between
25 mg/ml and 263 mg/ml the Ceftazidime
Sandoz powders for injection/infusion
may be mixed in commonly used
solutions for infusion:
0.9% sodium chloride solution
(physiological saline solution),
5% glucose solution,
0.9% sodium chloride + 5% glucose
solution,
Ringer Lactate Solution
When reconstituted for intramuscular
use, the Ceftazidime Sandoz powder for
injection/infusion can also be diluted with
1% lidocaine solutions.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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